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Cross Contamination

Updated:

Fresenius Kabi USA Dexmedetomidine HCL in 0.9% Sodium Chloride Injection - recalled due to cross contamination with Lidocaine, USA

3 years ago •source www.fda.gov

Recall notice

Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi USA
Product recalled: Dexmedetomidine HCL in 0.9% Sodium Chloride Injection
Reason of the recall: Cross Contamination with Lidocaine
FDA Recall date: November 19, 2020
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl … See More
in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the user level. To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction. 

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Listed below is a table of the recalled lot distributed nationwide to wholesalers, distributors, hospitals and pharmacies between April 9, 2020 and April 13, 2020. An image of the label is also included below.

- Dexmedetomidine HCl in 0.9%. Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. NDC Number: 63323-671-50. Product Code: 671050. Batch number: 6123925. Expiration Date: 03/2022. First Ship Date: 04/09/2020. Last Ship Date: 04/13/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking them to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Check the full recall details on www.fda.gov

Source: FDA
See Less

#drugs #recall #crosscontamination #us

Fresenius Kabi USA Dexmedetomidine HCL in 0.9% Sodium Chloride Injection - recalled due to cross contamination with Lidocaine photo #1
303

Recent Interesting Reports

G

I didnt order, 12800 Aldine Westfield Road, Houston, TX, USA

3 weeks ago •reported by user-gthb1157

I got a package i didnt order from a known scam artist.
I received a package of small circuits for a model aurplane from Donna Robinson 12800 aldine westfield rd in houston. Did nit irder this. Never heard of her. Not sure how she got my name … See More
and address. Very peculiar. I heard its a scam.
Package came from 12800 aldine westfield hiuston. Im in tyler tx
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I didnt order photo #1
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They took from me Credit Card, Emporia, VA 23847, USA

2 weeks ago •reported by user-cktw7545

This order this air pump a change for my car. For Mqc and never received it. They took my money from my account

They sent me something that I didn’t order
192-01 Northern Blvd flushing NY 11358 sent me some. KETO -ACV and I never ordered this

#scam #onlineshopping #onlinescam #delivery #emporia #virginia #us

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I received a bottle of subgenix in the mail that I did not order, Sault Ste. Marie, MI, USA

2 weeks ago •reported by user-kcyt3992

I did not order of request. I suspect this is a scam.
Received a bottle of Bioribose power made by the company I just named in todays mail. I am concerned about being billed for this, where it came from and how to protect my self and … See More
stop any further activity with this entity. I found a phone number for the company Subgenix Products in the bottle. 800-609-4174 and called it. The receptionist answered in a foreign language which sounded oriental and I also heard what sounded like Spanish. When I requested an English speaking person to assist, they hung up the phone. I called again with the same results.
See Less

#unorderedpackage #delivery #saultstemarie #michigan #us

I received a bottle of subgenix in the mail that I did not order photo #1
21

AuroMedics Pharma Methocarbamol Injection - recalled due to Particulate Matter presence, USA

4 weeks ago •source www.fda.gov

Recall notice

Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating … See More
inside of the vial.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Eugia US LLC has not received any reports of adverse events related to this recall.

Methocarbamol injection USP 1000 mg/10 mL (100mg/mL), is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is packaged in 10 mL and packed as 25 (vials) X 04 (Printed E-Flute cartons) X 01 (Shipper) with NDC code as 55150-223-10. Eugia US LLC shipped the entire lot to wholesalers nationwide from Jan 12, 2024, through Jan 16, 2024.

The product can be identified by product name on carton and vial label and with lot number 3MC23011 and Exp. Date: Nov 2026 (NDC 55150-223-10) (See enclosed vial label). The product label is as shown in the image below.

Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hospitals, pharmacies, institutions, and doctors with an existing inventory of the recalled product lot should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product lot, notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

If you are experiencing any harm after using this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: Eugia US LLC
Brand name: Eugia US LLC
Product recalled: Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)
Reason of the recall: Device & Drug Safety – Presence of Particulate Matter
FDA Recall date: March 28, 2024

Source: www.fda.gov
See Less

#drugs #recall #us

AuroMedics Pharma Methocarbamol Injection - recalled due to Particulate Matter presence photo #1
304

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